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FDA 510(k)

ONEDOSE PATIENT DOSIMETRY SYSTEM

K-Number: K040687 · 2004-06-25

ApplicantSicel Technologies, Inc.
Decision Date2004-06-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONEDOSE PATIENT DOSIMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sicel Technologies, Inc.. It received FDA 510(k) clearance on 2004-06-25 under 510(k) number K040687. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONEDOSE PATIENT DOSIMETRY SYSTEM?

ONEDOSE PATIENT DOSIMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Sicel Technologies, Inc.. The 510(k) number is K040687.

When did ONEDOSE PATIENT DOSIMETRY SYSTEM receive FDA 510(k) clearance?

ONEDOSE PATIENT DOSIMETRY SYSTEM received FDA 510(k) clearance on 2004-06-25, under 510(k) number K040687.

Who is the listed applicant for ONEDOSE PATIENT DOSIMETRY SYSTEM?

The FDA 510(k) record lists Sicel Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONEDOSE PATIENT DOSIMETRY SYSTEM?

The FDA product code for ONEDOSE PATIENT DOSIMETRY SYSTEM is IYE.

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Other records listing Sicel Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083035DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMK081859MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEMK080004DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMK071399DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100K061051DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETERK052118DOSE VERIFICATION SYSTEM

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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